Doctors, Drug Maker Dispute AIDS Study

C H I C A G O, Oct. 31

A study suggesting a vaccine-like AIDS treatment
is ineffective has erupted in a public dispute between the
manufacturer that paid for much of the study and doctors who say
the company tried to squelch their research.

The study is being published in Wednesday’s Journal of the
American Medical Association.

The study in question refers to a trial that was stopped in May 1999, according to Laura Hansen, spokeswoman for the company. Other trials are ongoing with the vaccine, including one started in September 1999 with another company that is still enrolling 550 patients. Another National Institutes of Health study, which began earlier this year, is on hold, she said.

The results of the JAMA study suggest that when added to the drug regimen for
HIV-infected patients, HIV-1 Immunogen failed to reduce the risk of
developing full-blown AIDS. The drug carries the brand name Remune.

Such data includes results showing that patients taking the vaccine and other new antiretroviral drugs had a decrease in the amount of virus in their blood compared to people who only took the drugs, Hansen says.

The company entered a fairly common arbitration process during
which it tried to produce “a more balanced manuscript,” said Dr.
Ronald Moss, the company’s vice president of medical and scientific
affairs.

Contract Violation?

Instead, the researchers violated their contractual agreement
and published incomplete findings, Moss said.

“It seems like tabloid journalism that JAMA would not
investigate this further” before publishing, Moss said.

HIV-1 Immunogen was developed by the late Dr. Jonas Salk, who
created the first polio vaccine. It was developed before powerful
“drug cocktails” including protease inhibitors became standard
HIV treatment, and Immune Response says subjects’ use of such drugs
affected the findings in the JAMA study.

Dr. James Kahn of the University of California at San Francisco,
the study’s lead author, said the company withheld important data
and then tried to suppress publication.

The company denies both claims. In an arbitration complaint last
month, Immune Response also demanded $7 million to $10 million from
Kahn and the university, claiming dissemination of the negative
findings caused it financial harm, UCSF attorney Christopher Patti
said.

Were Results Clinically Significant?

The study of 2,527 patients nationwide found that Remune did
boost levels of infection-fighting white blood cells, but the
authors questioned whether the effect was clinically significant.

The university contends Kahn was allowed to publish the results.

JAMA editor Dr. Catherine DeAngelis defended the journal’s
decision to publish. “This study stands on its own scientific
merit,” she said. “It was peer-reviewed as such.”

In a JAMA editorial, she said the dispute illustrates what can
happen when disagreement erupts between researchers and a funding
sponsor who “has a proprietary interest in the findings.”

Moss said the study was published without the consent of some of
the researchers. The company and one of the dissenting researchers,
Dr. John Turner of Graduate Hospital in Philadelphia, drafted a
letter Monday to DeAngelis, decrying publication of a manuscript
that contains “incomplete and inaccurate information.”

The final manuscript contains “some major statistical flaws,”
said Turner, who believes HIV-I Immunogen can slow disease
progression.

“If I were HIV-positive, I would batter down any door necessary
to get it, period,” Turner said.

ABCNEWS.com’s Robin Eisner and The Associated Press contributed to this report.